Trial Outcomes & Findings for Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia (NCT NCT00549718)
NCT ID: NCT00549718
Last Updated: 2014-06-11
Results Overview
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-06-11
Participant Flow
Participant milestones
| Measure |
Lurasidone 40mg
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
Lurasidone 40 mg tablets taken once/day
|
Placebo
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
125
|
123
|
124
|
128
|
|
Overall Study
COMPLETED
|
84
|
86
|
85
|
73
|
|
Overall Study
NOT COMPLETED
|
41
|
37
|
39
|
55
|
Reasons for withdrawal
| Measure |
Lurasidone 40mg
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
Lurasidone 40 mg tablets taken once/day
|
Placebo
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
Overall Study
Insufficient clinical response
|
20
|
7
|
18
|
32
|
|
Overall Study
Adverse Event
|
6
|
8
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
9
|
18
|
12
|
13
|
|
Overall Study
Administrative
|
2
|
2
|
2
|
1
|
Baseline Characteristics
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Lurasidone 40mg
n=122 Participants
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
n=119 Participants
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
n=124 Participants
Lurasidone 40 mg tablets taken once/day
|
Placebo
n=124 Participants
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
38.6 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
37.7 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
38.2 years
STANDARD_DEVIATION 9.9 • n=157 Participants
|
38.8 years
STANDARD_DEVIATION 10.5 • n=390 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
34 Participants
n=157 Participants
|
149 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
90 Participants
n=157 Participants
|
340 Participants
n=390 Participants
|
|
Region of Enrollment
France
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=157 Participants
|
3 participants
n=390 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
64 participants
n=107 Participants
|
70 participants
n=206 Participants
|
67 participants
n=157 Participants
|
271 participants
n=390 Participants
|
|
Region of Enrollment
Malaysia
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=157 Participants
|
8 participants
n=390 Participants
|
|
Region of Enrollment
Ukraine
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
14 participants
n=157 Participants
|
51 participants
n=390 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
9 participants
n=157 Participants
|
36 participants
n=390 Participants
|
|
Region of Enrollment
Russian Federation
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
13 participants
n=206 Participants
|
15 participants
n=157 Participants
|
57 participants
n=390 Participants
|
|
Region of Enrollment
India
|
14 participants
n=99 Participants
|
16 participants
n=107 Participants
|
17 participants
n=206 Participants
|
16 participants
n=157 Participants
|
63 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Outcome measures
| Measure |
Lurasidone 40mg
n=121 Participants
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
n=118 Participants
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
n=123 Participants
Lurasidone 40 mg tablets taken once/day
|
Placebo
n=124 Participants
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
|
-19.2 scores on a scale
Interval -22.6 to -15.7
|
-23.4 scores on a scale
Interval -26.9 to -19.9
|
-20.5 scores on a scale
Interval -24.0 to -17.1
|
-17.0 scores on a scale
Interval -20.5 to -13.6
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Outcome measures
| Measure |
Lurasidone 40mg
n=122 Participants
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
n=119 Participants
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
n=124 Participants
Lurasidone 40 mg tablets taken once/day
|
Placebo
n=124 Participants
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
CGI-S From Baseline to the End of the Double-blind Treatment
|
-1.1 scores on a scale
Interval -1.3 to -0.9
|
-1.4 scores on a scale
Interval -1.6 to -1.2
|
-1.2 scores on a scale
Interval -1.4 to -1.0
|
-1.0 scores on a scale
Interval -1.2 to -0.8
|
Adverse Events
Lurasidone 40mg
Serious events: 2 serious events
Other events: 96 other events
Deaths: 0 deaths
Lurasidone 80mg
Serious events: 3 serious events
Other events: 90 other events
Deaths: 0 deaths
Lurasidone 120mg
Serious events: 6 serious events
Other events: 106 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 40mg
n=124 participants at risk
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
n=121 participants at risk
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
n=124 participants at risk
Lurasidone 40 mg tablets taken once/day
|
Placebo
n=127 participants at risk
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/124 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/124 • 14 days post study therapy
|
0.79%
1/127 • 14 days post study therapy
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/124 • 14 days post study therapy
|
0.83%
1/121 • 14 days post study therapy
|
0.00%
0/124 • 14 days post study therapy
|
0.00%
0/127 • 14 days post study therapy
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/124 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/124 • 14 days post study therapy
|
0.79%
1/127 • 14 days post study therapy
|
|
Nervous system disorders
Complex Partial Seizures
|
0.81%
1/124 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/124 • 14 days post study therapy
|
0.00%
0/127 • 14 days post study therapy
|
|
Psychiatric disorders
Psychotic Disorders
|
0.00%
0/124 • 14 days post study therapy
|
0.83%
1/121 • 14 days post study therapy
|
0.81%
1/124 • 14 days post study therapy
|
2.4%
3/127 • 14 days post study therapy
|
|
Psychiatric disorders
Schizophrenia
|
0.81%
1/124 • 14 days post study therapy
|
0.83%
1/121 • 14 days post study therapy
|
4.0%
5/124 • 14 days post study therapy
|
0.79%
1/127 • 14 days post study therapy
|
Other adverse events
| Measure |
Lurasidone 40mg
n=124 participants at risk
Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
|
Lurasidone 80mg
n=121 participants at risk
lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
Lurasidone 120mg
n=124 participants at risk
Lurasidone 40 mg tablets taken once/day
|
Placebo
n=127 participants at risk
Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
6/124 • 14 days post study therapy
|
5.8%
7/121 • 14 days post study therapy
|
9.7%
12/124 • 14 days post study therapy
|
4.7%
6/127 • 14 days post study therapy
|
|
Gastrointestinal disorders
Nausea
|
11.3%
14/124 • 14 days post study therapy
|
6.6%
8/121 • 14 days post study therapy
|
12.1%
15/124 • 14 days post study therapy
|
7.1%
9/127 • 14 days post study therapy
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
5/124 • 14 days post study therapy
|
5.8%
7/121 • 14 days post study therapy
|
9.7%
12/124 • 14 days post study therapy
|
3.9%
5/127 • 14 days post study therapy
|
|
Investigations
Weight Increase
|
4.8%
6/124 • 14 days post study therapy
|
3.3%
4/121 • 14 days post study therapy
|
7.3%
9/124 • 14 days post study therapy
|
2.4%
3/127 • 14 days post study therapy
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
3/124 • 14 days post study therapy
|
5.8%
7/121 • 14 days post study therapy
|
1.6%
2/124 • 14 days post study therapy
|
1.6%
2/127 • 14 days post study therapy
|
|
Nervous system disorders
Akathisia
|
11.3%
14/124 • 14 days post study therapy
|
17.4%
21/121 • 14 days post study therapy
|
24.2%
30/124 • 14 days post study therapy
|
51.2%
65/127 • 14 days post study therapy
|
|
Nervous system disorders
Dystonia
|
4.8%
6/124 • 14 days post study therapy
|
7.4%
9/121 • 14 days post study therapy
|
2.4%
3/124 • 14 days post study therapy
|
0.79%
1/127 • 14 days post study therapy
|
|
Nervous system disorders
Headache
|
18.5%
23/124 • 14 days post study therapy
|
13.2%
16/121 • 14 days post study therapy
|
16.9%
21/124 • 14 days post study therapy
|
15.7%
20/127 • 14 days post study therapy
|
|
Nervous system disorders
Parkinsonism
|
6.5%
8/124 • 14 days post study therapy
|
4.1%
5/121 • 14 days post study therapy
|
9.7%
12/124 • 14 days post study therapy
|
0.00%
0/127 • 14 days post study therapy
|
|
Nervous system disorders
Sedation
|
5.6%
7/124 • 14 days post study therapy
|
10.7%
13/121 • 14 days post study therapy
|
10.5%
13/124 • 14 days post study therapy
|
4.7%
6/127 • 14 days post study therapy
|
|
Nervous system disorders
Somnolence
|
10.5%
13/124 • 14 days post study therapy
|
9.9%
12/121 • 14 days post study therapy
|
14.5%
18/124 • 14 days post study therapy
|
5.5%
7/127 • 14 days post study therapy
|
|
Psychiatric disorders
Agitation
|
5.6%
7/124 • 14 days post study therapy
|
2.5%
3/121 • 14 days post study therapy
|
5.6%
7/124 • 14 days post study therapy
|
1.6%
2/127 • 14 days post study therapy
|
|
Psychiatric disorders
Insomnia
|
6.5%
8/124 • 14 days post study therapy
|
7.4%
9/121 • 14 days post study therapy
|
4.8%
6/124 • 14 days post study therapy
|
7.9%
10/127 • 14 days post study therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by DSP-Sepracor.
- Publication restrictions are in place
Restriction type: OTHER